Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012035815

FEI Number

3012035815

Entity Name

LEGWORKS

City/State/Country

Buffalo, NY, US

Establishment Address

701 Ellicott Street, Buffalo, NY 14203, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LegWorks (Owner Number: 10050263)

Owner / Operator Contact Address

701 Ellicott Street, Buffalo, NY 14203, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AT-Knee All-Terrain Knee All-Terrain Knee with Stance Flexion All-Terrain Knee Premium All-Terrain Knee Premium with Stance Flexion ATK HydraPro with Stance Flexion ATK HydraPro ATK HydraPro Knee with Threaded Top All-Terrain Knee Premium HD All-Terrain Knee with Threaded Top ATK HydraPro Knee HD with Stance Flexion ATK HydraPro Knee HD All-Terrain Knee Premium with Threaded Top All-Terrain Knee Premium HD with Threaded Top All-Terrain Knee Premium HD with Stance Flexion ATK HydraPro Knee HD with Threaded Top

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISY	Joint, Knee, External Limb Component	Physical Medicine	Class 1	890.3420	2015-10-26

Official Correspondent

Brandon Burke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LegWorks

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3005245962	TIMED INC.	Torrance, CA, US
1834241	College Park Industries	Warren, MI, US
8010401	STREIFENEDER ortho.production gmbH	EMMERING Bavaria, DE
1043533	U.S. ORTHOTICS, INC.	Tampa, FL, US
1926174	Brownmed	Spirit Lake, IA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012035815. Last updated year: 2026. Please use registration number 3012035815 when referencing this establishment in official correspondence.